Hematologic DiseasesNCT00223483
Identification and Analysis of Immunomodulatory Molecules in Patients With Hematologic Disorders and Healthy Volunteers
An observational study of Hematologic Diseases and Healthy Volunteers, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
This research study goal is to analyze the plasma and the cells that make up part of the immune system. We want to learn how the plasma and cells work. These may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Diseases, Healthy Volunteers
- What is being tested?
- Isolation of genomic DNA
- How many people
- 512 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2005to 14 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic and community samples
Who may be able to join
- Must be able to give blood
- Must be able to give informed consent
- Signed, written informed consent
Who cannot join
- Individuals with a history severe anemia, inadequate venous access, severe blood or coagulation disorders.
- Pregnant women are excluded because it is a unique immunotolerant state and will alter the profile of immunomodulatory molecules.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Department of Veterans Affairs, South Texas Veterans Health Care System, Audie L. Murphy Memorial Veterans Hospital Division
San Antonio, Texas, 78229
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Identification and Analysis of Immunomodulatory Molecules From Leukocytes in Patients With Hematologic Disorders and Healthy Volunteers
This research study goal is to analyze the plasma and the cells that make up part of the immune system. We want to learn how the plasma and cells work. These may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms.
Read the detailed description
This research study goal is to analyze the plasma and the cells that make up part of the immune system. These cells, called white cells or leukocytes, are present in blood. We want to learn how these cells work to prevent infection and how they respond after an infection occurs. We also want to study certain molecules present on the plasma, on or in these cells, and the genetic material that allows these molecules to be made. These molecules may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms. This study may increase our understanding of a variety of diseases including infections such as HIV, allergic diseases such as asthma, joint diseases such as rheumatoid arthritis, certain cancers, and the rejection process that sometimes occurs after transplantation of an organ.
- Conditions
- Hematologic Diseases, Healthy Volunteers
- Being tested
- Isolation of genomic DNA
- Keywords
- Hematologic Diseases, Genomics, Cytokines, Chemokines, Receptors
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of genomic DNAGenetic
One time blood draw
What is being measured
The primary outcome is the main question the study is designed to answer.
Repository collection of plasma and serum for future analysis.
Measured: 12 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2005
- Primary completion11 Dec 2020
- Study completion14 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 512 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Cesar O Freytes, MD, Study director, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223483
- Sponsor's protocol ID
- HSC20040268H
- Status last verified
- Jul 2021
- First submitted
- 13 Sep 2005
- Last updated
- 16 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification and Analysis of Immunomodulatory Molecules From Leukocytes in Patients With Hematologic Disorders and Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00223483
- Acronym / sponsor ID
- HSC20040268H
- Conditions
- Hematologic Diseases, Healthy Volunteers
- Keywords
- Hematologic Diseases, Genomics, Cytokines, Chemokines, Receptors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 512 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- Mar 2005
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 14 Jul 2021 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study goal is to analyze the plasma and the cells that make up part of the immune system. We want to learn how the plasma and cells work. These may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms.
Detailed description
This research study goal is to analyze the plasma and the cells that make up part of the immune system. These cells, called white cells or leukocytes, are present in blood. We want to learn how these cells work to prevent infection and how they respond after an infection occurs. We also want to study certain molecules present on the plasma, on or in these cells, and the genetic material that allows these molecules to be made. These molecules may influence why one person will develop an infection and another will not, or why one person develops severe symptoms of a disease while others remain without symptoms. This study may increase our understanding of a variety of diseases including infections such as HIV, allergic diseases such as asthma, joint diseases such as rheumatoid arthritis, certain cancers, and the rejection process that sometimes occurs after transplantation of an organ.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic and community samples
Key inclusion criteria (3 listed)
- Must be able to give blood
- Must be able to give informed consent
- Signed, written informed consent
Key exclusion criteria (2 listed)
- Individuals with a history severe anemia, inadequate venous access, severe blood or coagulation disorders.
- Pregnant women are excluded because it is a unique immunotolerant state and will alter the profile of immunomodulatory molecules.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Isolation of genomic DNAOne time blood draw | Genetic | – |
Primary outcome
Repository collection of plasma and serum for future analysis.
Time frame: 12 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesar O Freytes, MD study director
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Diseases and Healthy Volunteers, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repository collection of plasma and serum for future analysis. (time frame: 12 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.